Cincinnati Sub-Zero Products LLC, a Gentherm Company Recalls

CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

Class I - Dangerous

Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes

Jul 2, 2019 Infusion Pumps Nationwide View Details →

Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

Class I - Dangerous

Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes

Jul 2, 2019 Infusion Pumps Nationwide View Details →

Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

Class I - Dangerous

Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes

Jul 2, 2019 Infusion Pumps Nationwide View Details →

Norm-O-Temp model 111Z

Class I - Dangerous

The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

Jun 20, 2019 Other Medical Devices Nationwide View Details →

Norm-O-Temp model 111W

Class I - Dangerous

The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

Jun 20, 2019 Other Medical Devices Nationwide View Details →

MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.

Class I - Dangerous

Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage

Jul 19, 2019 Infusion Pumps Nationwide View Details →

Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper / hypothermia blanket under the patient to provide warming through conductive heat transfer.

Class I - Dangerous

Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led to discoloration on the board due to overheating and shut down of the device.

Dec 19, 2018 Infusion Pumps Nationwide View Details →

Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.

Class I - Dangerous

Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.

Sep 4, 2018 Infusion Pumps Nationwide View Details →